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Citation
Landis, Richard (2021). Chronic Prostatitis Collaborative Research Network Cohort Study (CPCRN Cohort) (Version 2) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/y7xf-s477
Data Availability Statement
Data from the Chronic Prostatitis Collaborative Research Network Cohort Study (CPCRN Cohort) [(Version 2) https://doi.org/10.58020/y7xf-s477] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The CPCRN Cohort study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the CPCRN Cohort (https://doi.org/10.58020/y7xf-s477) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the CPCRN Cohort study and does not necessarily reflect the opinions or views of the CPCRN Cohort study, NIDDK-CR, or NIDDK.
Data Package Version
Version 2 (Updated on: Feb 24, 2021)
Resource Availability
  • Data Available for Request
  • Specimens Not Available
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General Description

Chronic prostatitis is a disabling condition of unknown origin affecting men of all ages and ethnic groups. Most have chronic pelvic pain associated with urinary frequency and urgency; however, they do not have demonstrable urinary or prostatic infections that can be detected by conventional microbiological techniques. In response to the growing concerns about the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), the Chronic Prostatitis Collaborative Research Network (CPCRN), which consists of six clinical centers and one data coordinating center, was established to study this syndrome in order to improve diagnosis and treatment.

The CPCRN conducted a prospective observational cohort study designed to characterize CP/CPPS, examine symptoms and quality of life in affected men, and assess the economic impact of the condition. Men of any age with symptoms of discomfort or pain in the pelvic region for at least 3 of the 6 months prior were eligible for enrollment. The CPCRN cohort study consisted of a baseline screening phase and a longitudinal follow-up phase. During the baseline screening phase, eligibility criteria were assessed, and baseline data and biospecimens (including serum, prostatic fluid, and semen) were collected. Information on symptoms and quality of life, demographic and lifestyle factors, medical history, prior treatments and procedures, and health resource utilization was collected.

The study found that CP/CPPS is a multifactorial problem affecting men of all ages and demographics. The condition is characterized by substantial variation in symptoms within and among subjects. There is no evidence that the disorder worsens significantly during 2 years of follow-up, and for about a third of men with long-standing symptoms there may be moderate to marked improvement during this period. Men with chronic prostatitis experience impairment in the mental and physical domains of general health related quality of life, and many have benefited only minimally from empirical, goal-directed therapy. The CPCRN has conducted numerous clinical trials to investigate the safety and efficacy of numerous treatments for CP/CPPS, for which more details are available on the NIDDK Repository website.

Objectives

The primary objective of the study was to characterize CP/CPPS by examining the diagnosis, symptoms, and quality of life in affected men and assessing the economic impact of the condition.

Outcome Measure

Clinical and laboratory values from physical examination and laboratory studies, the NIH Chronic Prostatitis Symptom Index (NIH-CPSI), and quality of life assessments were used as outcome measures.

Eligibility Criteria

Participants included men of all ages who had experienced symptoms of discomfort or pain in the pelvic region for at least 3 of the 6 months prior to the baseline screening visit. Men who had used antimicrobial agents, had an active genitourinary infection, or a prostate biopsy within the past three months were deferred for 3 months, and at that time they were allowed to enter into the study.

Exclusion criteria are documented in the study protocol.

Outcome

The study found that CP/CPPS is a multifactorial problem affecting men of all ages and demographics. The condition is characterized by substantial variation in symptoms within and among subjects. There is no evidence that the disorder worsens significantly during 2 years of follow-up, and for about a third of men with long-standing symptoms there may be moderate to marked improvement during this period. Men with chronic prostatitis experience impairment in the mental and physical domains of general health related quality of life, and many have benefited only minimally from empirical, goal-directed therapy. The CPCRN has conducted numerous clinical trials to investigate the safety and efficacy of numerous treatments for CP/CPPS, for which more details are available on the NIDDK Repository website.

Research Area

Urologic Diseases

Study Type

Observational

Study Sites

6

Condition

Prostatitis

Keywords

Pelvic Pain, Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Prostatic Disease, Chronic Prostatitis, NIH Chronic Prostatitis Symptom Index (NIH-CPSI), Urogenital Disease

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases

488
Participants

Target Population
Adults

Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
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Non-Public Documents (40)
Non-Public Documents Table
Document Name
Description
Document Type
File Format
Datasets (39)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Patient Withdrawal Form Dataset
Contains data from the Patient Withdrawal Form149sas7bdat (17 KB); csv (6.4 KB)
Serum Sample Form Dataset
Contains data from the Serum Sample Form487sas7bdat (41 KB); csv (26.2 KB)
Four Glass Test Specimen Cultures Form Dataset
Contains data from the Four Glass Test Specimen Cultures Form1106sas7bdat (193 KB); csv (96.49 KB)
Four Glass Test Specimen Cultures Form - 07a Dataset
Contains data from the Four Glass Test Specimen Cultures Form - 07a1308sas7bdat (81 KB); csv (31.25 KB)
Semen Sample Form - 09a Dataset
Contains data from the Semen Sample Form - 09a697sas7bdat (49 KB); csv (16.63 KB)
Four Glass Test Specimen Cultures Form - 10a Dataset
Contains data from the Four Glass Test Specimen Cultures Form - 10a1175sas7bdat (73 KB); csv (27.99 KB)
Medical History Form Dataset
Contains data from the Medical History Form488sas7bdat (273 KB); csv (83.91 KB)
Resource Utilization Survey Form - 07 Dataset
Contains data from the Resource Utilization Survey Form - 0716sas7bdat (9 KB); csv (434 B)
Screening Confirmation Form Dataset
Contains data from the Screening Confirmation Form488sas7bdat (49 KB); csv (37.27 KB)
Resource Utilization Survey Form - 05 Dataset
Contains data from the Resource Utilization Survey Form - 05258sas7bdat (25 KB); csv (8.42 KB)
Epidemiologic History Form Dataset
Contains data from the Epidemiologic History Form487sas7bdat (248 KB); csv (68.08 KB)
Symptom Index Dataset
Contains data from the Symptom Index5338sas7bdat (1.38 MB); csv (493.86 KB)
Semen Sample Form Dataset
Contains data from the Semen Sample Form487sas7bdat (73 KB); csv (41.96 KB)
Four Glass Test Specimen Cultures Form - 02a Dataset
Contains data from the Four Glass Test Specimen Cultures Form - 02a1584sas7bdat (97 KB); csv (38.1 KB)
Prior Treatments and Procedures Form Dataset
Contains data from the Prior Treatments and Procedures Form488sas7bdat (145 KB); csv (45.2 KB)
Concomitant Medications Form Dataset
Contains data from the Concomitant Medications Form486sas7bdat (61 KB); csv (27.18 KB)
Urethral Swab Form Dataset
Contains data from the Urethral Swab Form485sas7bdat (41 KB); csv (25.62 KB)
Baseline Dataset
A summary analysis data file for all data collected at baseline488sas7bdat (5.26 MB); csv (1.27 MB)
Four Glass Test Specimen Cultures Form - 14a Dataset
Contains data from the Four Glass Test Specimen Cultures Form - 14a1380sas7bdat (81 KB); csv (32.98 KB)
Voiding Log Form Dataset
Contains data from the Voiding Log Form1126sas7bdat (169 KB); csv (100.13 KB)
Analysis Dataset
A summary analysis data file for all data collected for the "CPC Control Group Study" Ancillary study584sas7bdat (6.32 MB); csv (1.63 MB)
Uroflow Study Form Dataset
Contains data from the Uroflow Study Form488sas7bdat (49 KB); csv (26.37 KB)
Semen Sample Form - 07a Dataset
Contains data from the Semen Sample Form - 07a644sas7bdat (41 KB); csv (15.35 KB)
Resource Utilization Survey Form - 03 Dataset
Contains data from the Resource Utilization Survey Form - 0321sas7bdat (9 KB); csv (526 B)
Patient Reinstatement Form Dataset
Contains data from the Patient Reinstatement Formsas7bdat (9 KB); csv (59 B)
Physical Exam Form Dataset
Contains data from the Physical Exam Form1831sas7bdat (561 KB); csv (207.96 KB)
Four Glass Test Specimen Cultures Form - 05a Dataset
Contains data from the Four Glass Test Specimen Cultures Form - 05a1139sas7bdat (73 KB); csv (28.08 KB)
Deferral Checklist Form Dataset
Contains data from the Deferral Checklist Form488sas7bdat (73 KB); csv (30.17 KB)
Four Glass Test Microscopy Dataset
Contains data from the Four Glass Test Microscopy1835sas7bdat (561 KB); csv (198.59 KB)
Exclusion Checklist Form Dataset
Contains data from the Exclusion Checklist Form488sas7bdat (73 KB); csv (30.18 KB)
Longitudinal Dataset
A summary analysis data file for all data collected during the longitudinal study phase6675sas7bdat (20.95 MB); csv (7.24 MB)
Resource Utilization Survey Form Log Dataset
Contains data from the Resource Utilization Survey Form Log167sas7bdat (33 KB); csv (26.77 KB)
Inclusion Checklist Form Dataset
Contains data from the Inclusion Checklist Form488sas7bdat (57 KB); csv (28.69 KB)
Four Glass Test Specimen Cultures Form - 09a Dataset
Contains data from the Four Glass Test Specimen Cultures Form - 09a1659sas7bdat (97 KB); csv (39.92 KB)
Patient Completion Form Dataset
Contains data from the Patient Completion Form276sas7bdat (33 KB); csv (21.61 KB)
Four Glass Test Specimen Cultures Form - 03a Dataset
Contains data from the Four Glass Test Specimen Cultures Form - 03a1116sas7bdat (65 KB); csv (26.57 KB)
Resource Utilization Survey Form - 010 Dataset
Contains data from the Resource Utilization Survey Form - 010128sas7bdat (17 KB); csv (4.57 KB)
Four Glass Test Specimen Cultures Form - 12a Dataset
Contains data from the Four Glass Test Specimen Cultures Form - 12a1252sas7bdat (73 KB); csv (30.84 KB)
Interim Health Care Form Dataset
Contains data from the Interim Health Care Form1497sas7bdat (529 KB); csv (175.05 KB)
Specimens (0)
There are currently no specimens available